Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03412890
Recruitment Status : Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Brief Summary:
The purpose of this study is to determine the long-term efficacy of Relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on heavy menstrual bleeding associated with uterine fibroids in patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002).

Condition or disease Intervention/treatment Phase
Heavy Menstrual Bleeding Uterine Fibroid Drug: Relugolix Drug: Estradiol/norethindrone acetate Phase 3

Detailed Description:

This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible patients who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All patients will receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.

Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose estradiol/norethindrone acetate.

Screening and baseline procedures will be done at the same visit for this extension study (referred to as the "Week 24/Baseline Visit"), which coincides with the Week 24 visit from the parent study, and will be defined as the date of completion of the last Week 24 procedure in the parent study. Patients will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the patient is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 28 weeks.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-Label Extension
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : July 30, 2020


Arm Intervention/treatment
Experimental: Relugolix plus E2/NETA
Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks
Drug: Relugolix
Relugolix 40 mg tablet administered orally once daily
Other Name: TAK-385

Drug: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Other Name: E2/NETA, low-dose hormonal add-back




Primary Outcome Measures :
  1. Responder rate based on reduction in menstrual blood loss (MBL) volume [ Time Frame: from Parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks ]
    Defined as the proportion of women who achieve a MBL volume of < 80 mL and a ≥ 50% reduction from parent study Baseline MBL volume over the last 35 days of treatment. MBL volume is measured using the alkaline hematin method.


Secondary Outcome Measures :
  1. Time to MBL response [ Time Frame: up to 52 weeks ]
    Defined as the time to achieve a MBL volume of < 80 mL and a ≥ 50% reduction from parent study Baseline MBL volume as measured by the alkaline hematin method.

  2. Change in MBL volume [ Time Frame: from parent study Baseline up to Week 52 ]
    MBL volume is measured using the alkaline hematin method.

  3. Proportion of women with suppression of bleeding [ Time Frame: from parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks ]
    Will be assessed using patient daily diary and MBL volume measured using the alkaline hematin method.

  4. Change in hemoglobin concentration [ Time Frame: from parent study Baseline up to Week 52 ]
    Blood samples will be collected from participants for hemoglobin measurements.

  5. Change in uterine volume [ Time Frame: from parent study Baseline up to Week 52 ]
    Volume of the uterus will be measured by transvaginal or transabdominal ultrasound.

  6. Change in primary fibroid volume [ Time Frame: from parent study Baseline up to Week 52 ]
    Volume of the primary fibroid will be measured by transvaginal or transabdominal ultrasound.

  7. Change in impact on quality of life [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL).

  8. Bone Mineral Density (BMD) [ Time Frame: from parent study Baseline up to Week 52 ]
    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

  9. The number and percentage of participants with adverse events (AE) as a measure of safety and tolerability [ Time Frame: up to 52 weeks ]
    Assessed by frequency and severity of AEs and serious AEs.

  10. Serum estradiol concentrations [ Time Frame: up to 52 weeks ]
    Blood samples will be collected from participants for estradiol measurements.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

1. Completed 24 weeks of study drug treatment and study participation in either MVT‑601‑3001 or MVT‑601‑3002

Key Exclusion Criteria:

  1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the parent study (MVT‑601‑3001 or MVT‑601‑3002)
  2. Met a withdrawal criterion in the parent study (MVT‑601‑3001 or MVT‑601‑3002).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412890


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Andaluisa
Andalusia, Alabama, United States, 36420
Birmingham
Birmingham, Alabama, United States, 35205
Mobile
Mobile, Alabama, United States, 36608
United States, Arizona
Mesa
Mesa, Arizona, United States, 85209
Tucson
Tucson, Arizona, United States, 85712
United States, Arkansas
Little Rock
Little Rock, Arkansas, United States, 72205
United States, California
Canoga Park
Canoga Park, California, United States, 91303
Huntington Beach
Huntington Beach, California, United States, 92647
La Mesa
La Mesa, California, United States, 91942
Long Beach
Long Beach, California, United States, 90806
Los Angeles
Los Angeles, California, United States, 90036
Los Angeles
Los Angeles, California, United States, 90057
Norwalk
Norwalk, California, United States, 90650
Panorama
Panorama City, California, United States, 91402
San Diego
San Diego, California, United States, 92108
San Diego
San Diego, California, United States, 92111
United States, Colorado
Denver
Denver, Colorado, United States, 80209
Lakewood
Lakewood, Colorado, United States, 80228
United States, District of Columbia
Washington
Washington, District of Columbia, United States, 20036
United States, Florida
Aventura
Aventura, Florida, United States, 33180
Clearwater
Clearwater, Florida, United States, 33759
DeLand
DeLand, Florida, United States, 32720
Ft. Lauderdale
Fort Lauderdale, Florida, United States, 33316
Fort Myers
Fort Myers, Florida, United States, 33912
Hialeah
Hialeah, Florida, United States, 33016
Jacksonville
Jacksonville, Florida, United States, 32207
Jupiter
Jupiter, Florida, United States, 33458
Loxahachee
Loxahatchee Groves, Florida, United States, 33470
Margate
Margate, Florida, United States, 33063
Miami
Miami, Florida, United States, 33126
Miami
Miami, Florida, United States, 33155
Miami
Miami, Florida, United States, 33165
New Port Richey
New Port Richey, Florida, United States, 34652
Orlando
Orlando, Florida, United States, 32808
Oviedo
Oviedo, Florida, United States, 32765
Palm Harbor
Palm Harbor, Florida, United States, 34684
Plantation
Plantation, Florida, United States, 33324
Saint Cloud
Saint Cloud, Florida, United States, 34769
Sarasota
Sarasota, Florida, United States, 34239
Tampa
Tampa, Florida, United States, 33606
Tampa
Tampa, Florida, United States, 33613
West Palm Beach
West Palm Beach, Florida, United States, 33409
Weston
Weston, Florida, United States, 33327
United States, Georgia
Atlanta
Atlanta, Georgia, United States, 30342
Atlanta
Atlanta, Georgia, United States, 30363
Augusta
Augusta, Georgia, United States, 30912
College Park
College Park, Georgia, United States, 30349
Decatur
Decatur, Georgia, United States, 30034
Duluth
Duluth, Georgia, United States, 30097
Norcross
Norcross, Georgia, United States, 30093
Savannah
Savannah, Georgia, United States, 31406
United States, Idaho
Idaho Falls
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Chicago
Chicago, Illinois, United States, 60611
Naperville
Naperville, Illinois, United States, 60540
Oakbrook
Oakbrook Terrace, Illinois, United States, 60523
United States, Kansas
Shawnee
Shawnee Mission, Kansas, United States, 66218
United States, Louisiana
Covington
Covington, Louisiana, United States, 70433
Marrero
Marrero, Louisiana, United States, 70072
Metairie
Metairie, Louisiana, United States, 70001
Metairie
Metairie, Louisiana, United States, 70006
United States, Maryland
Baltimore
Baltimore, Maryland, United States, 21208
Towson
Towson, Maryland, United States, 21204
United States, Michigan
Canton
Canton, Michigan, United States, 48187
Detroit
Detroit, Michigan, United States, 48201
Saginaw
Saginaw, Michigan, United States, 48604
United States, Nebraska
Lincoln
Lincoln, Nebraska, United States, 68510
Omaha
Omaha, Nebraska, United States, 68124
United States, Nevada
Las Vegas
Las Vegas, Nevada, United States, 89106
Las Vegas
Las Vegas, Nevada, United States, 89109
Las Vegas
Las Vegas, Nevada, United States, 89113
Las Vegas
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Lawrenceville
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Albuquerque
Albuquerque, New Mexico, United States, 87102
United States, New York
Brooklyn
Brooklyn, New York, United States, 11201
New York
New York, New York, United States, 10022
Williamsville
Williamsville, New York, United States, 14221
United States, North Carolina
Durham
Durham, North Carolina, United States, 27713
Raleigh
Raleigh, North Carolina, United States, 27607
Raleigh
Raleigh, North Carolina, United States, 27612
Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati
Cincinnati, Ohio, United States, 45212
Cincinnati
Cincinnati, Ohio, United States, 45219
Columbus
Columbus, Ohio, United States, 43231
Englewood
Englewood, Ohio, United States, 45322
United States, Pennsylvania
Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Bluffton
Bluffton, South Carolina, United States, 29910
Charleston
Charleston, South Carolina, United States, 29406
Columbia
Columbia, South Carolina, United States, 29201
United States, Tennessee
Chattanooga
Chattanooga, Tennessee, United States, 37404
Memphis
Memphis, Tennessee, United States, 38119
Memphis
Memphis, Tennessee, United States, 38120
United States, Texas
Beaumont
Beaumont, Texas, United States, 77702
Dallas
Dallas, Texas, United States, 75231
Fort Worth
Fort Worth, Texas, United States, 76104
Frisco
Frisco, Texas, United States, 75035
Houston
Houston, Texas, United States, 77030
Houston
Houston, Texas, United States, 77054
Houston
Houston, Texas, United States, 77074
Irving
Irving, Texas, United States, 75062
Longview
Longview, Texas, United States, 75605
San Antonio
San Antonio, Texas, United States, 78229
San Antonio
San Antonio, Texas, United States, 78258
Sugar Land
Sugar Land, Texas, United States, 77479
Webster
Webster, Texas, United States, 77598
United States, Utah
Salt Lake City
Salt Lake City, Utah, United States, 84107
Salt Lake City
Salt Lake City, Utah, United States, 84124
United States, Virginia
Norfolk
Norfolk, Virginia, United States, 23502
Norfolk
Norfolk, Virginia, United States, 23507
Richmond
Richmond, Virginia, United States, 23225
United States, Washington
Seattle
Seattle, Washington, United States, 98105
Spokane
Spokane, Washington, United States, 99207
Belgium
La Louvière
La Louvière, Hainaut, Belgium, 7100
Gent
Gent, Oost-vlaanderen, Belgium, 9000
Brussels
Brussels, Belgium, 1200
Jette
Jette, Belgium, 1090
Brazil
Santo Andre
Santo André, Santo Andre, Brazil, 09190-510
Santo André
Santo André, SAO Paulo, Brazil, 09190-510
Sao Paulo
São Paulo, Sao Paulo, Brazil, 01317-000
Sao Paulo
São Paulo, Sao Paulo, Brazil, 04266-010
Botucatu
Botucatu, Brazil, 18618-686
Porto Alegre
Porto Alegre, Brazil, 90035-903
Porto Alegre
Porto Alegre, Brazil, 90510-040
Chile
Providencia
Providencia, Chile, 7510186
San Ramon
San Ramón, Chile, 8880465
Region Metropolitana
Santiago, Chile, 8320165
Santiago
Santiago, Chile, 8360160
Czechia
Jihlava
Jihlava, Czechia, 586 33
Olomouc
Olomouc, Czechia, 772 00
Pisek
Písek, Czechia, 39701
Ceské Budejovice
České Budějovice, Czechia, 370 01
Hungary
Kecskemét
Kecskemét, Bacs-kiskun, Hungary, 6000
Gyula
Gyula, Bekes, Hungary, 5700
Debrecen
Debrecen, Hajdu-bihar, Hungary, 4024
Nyíregyháza
Nyíregyháza, Szabolcs-Szatmar-Bereg, Hungary, 4400
Debrecen
Debrecen, Hungary, 4025
Szentes
Szentes, Hungary, 6600
Italy
Catanzaro
Catanzaro, Italy, 88100
Firenze
Firenze, Italy, 50134
Roma
Roma, Italy, 00168
Siena
Siena, Italy, 53100
Torino
Torino, Italy, 10126
Poland
Lódz
Lódz, Lodzkie, Poland, 90-602
Lublin
Lublin, Lubelskie, Poland, 20-632
Warszawa
Warszawa, Mazowieckie, Poland, 02-201
Katowice
Katowice, Slaskie, Poland, 40-123
Poznan
Poznań, Wielkopolskie, Poland, 60-192
Szczecin
Szczecin, Zachodniopomorskie, Poland, 71-270
Bialystok
Białystok, Poland, 15-464
South Africa
Centurion
Centurion, Gauteng, South Africa, 0157
Roodepoort
Roodepoort, Gauteng, South Africa, 1724
Durban
Durban, Kwazulu-natal, South Africa, 4126
Bloemfontein
Bloemfontein, South Africa, 9301
Cape Town
Cape Town, South Africa, 7405
Cape Town
Cape Town, South Africa, 7500
Port Elizabeth
Port Elizabeth, South Africa, 6001
Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
Layout table for investigator information
Study Director: Myovant Medical Monitor, MD Myovant Sciences

Layout table for additonal information
Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03412890     History of Changes
Other Study ID Numbers: MVT-601-3003
2017-003310-74 ( EudraCT Number )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leiomyoma
Myofibroma
Menorrhagia
Hemorrhage
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone Acetate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral